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Simultaneous determination of fixed dose combination of nebivolol and valsartan in human plasma by liquid chromatographic-tandem mass spectrometry and its application to pharmacokinetic study.
- Source :
-
Journal of chromatography. B, Analytical technologies in the biomedical and life sciences [J Chromatogr B Analyt Technol Biomed Life Sci] 2007 Oct 15; Vol. 858 (1-2), pp. 143-50. Date of Electronic Publication: 2007 Aug 22. - Publication Year :
- 2007
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Abstract
- A rapid, sensitive and accurate liquid chromatographic-tandem mass spectrometry method is described for the simultaneous determination of nebivolol and valsartan in human plasma. Nebivolol and valsartan were extracted from plasma using acetonitrile and separated on a C18 column. The mobile phase consisting of a mixture of acetonitrile and 0.05 mM formic acid (50:50 v/v, pH 3.5) was delivered at a flow rate of 0.25 ml/min. Atmospheric pressure ionization (API) source was operated in both positive and negative ion mode for nebivolol and valsartan, respectively. Selected reaction monitoring mode (SRM) using the transitions of m/z 406.1-->m/z 150.9; m/z 434.2-->m/z 179.0 and m/z 409.4-->m/z 228.1 were used to quantify nebivolol, valsartan and internal standard (IS), respectively. The linearity was obtained over the concentration range of 0.01-50.0 ng/ml and 1.0-2000.0 ng/ml and the lower limits of quantitation were 0.01 ng/ml and 1.0 ng/ml for nebivolol and valsartan, respectively. This method was successfully applied to the pharmacokinetic study of fixed dose combination (FDC) of nebivolol and valsartan formulation product after an oral administration to healthy human subjects.
- Subjects :
- Administration, Oral
Antihypertensive Agents administration & dosage
Antihypertensive Agents blood
Antihypertensive Agents pharmacokinetics
Benzopyrans administration & dosage
Benzopyrans pharmacokinetics
Drug Combinations
Ethanolamines administration & dosage
Ethanolamines pharmacokinetics
Humans
Nebivolol
Reproducibility of Results
Tetrazoles administration & dosage
Tetrazoles pharmacokinetics
Valine administration & dosage
Valine blood
Valine pharmacokinetics
Valsartan
Benzopyrans blood
Chromatography, Liquid methods
Ethanolamines blood
Tandem Mass Spectrometry methods
Tetrazoles blood
Valine analogs & derivatives
Subjects
Details
- Language :
- English
- ISSN :
- 1570-0232
- Volume :
- 858
- Issue :
- 1-2
- Database :
- MEDLINE
- Journal :
- Journal of chromatography. B, Analytical technologies in the biomedical and life sciences
- Publication Type :
- Academic Journal
- Accession number :
- 17884739
- Full Text :
- https://doi.org/10.1016/j.jchromb.2007.08.016